RECOMMENDATIONS FOR OFF-LABEL USE OF INTRAVENOUSLY ADMINISTERED IMMUNOGLOBULIN PREPARATIONS
RECOMMENDATIONS FOR OFF-LABEL USE OF INTRAVENOUSLY ADMINISTERED IMMUNOGLOBULIN PREPARATIONS
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DOI：
10.1001/jama.273.23.1865
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发表时间：
1995-06-21
影响因子：
120.7
通讯作者：
YOCUM, DE
中科院分区：
文献类型：
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作者：
RATKO, TA;BURNETT, DA;YOCUM, DE
客观。-总结大学医院联盟（UHC）专家小组制定的标准静脉注射免疫球蛋白（IVIG）标签外使用的共识建议。这些发现旨在帮助指导临床医生适当和有效地使用IVIG。UHC赞助的小组包括八名医生（重症监护，血液学，免疫学，神经学，肿瘤学，儿科或风湿病学的委员会认证）和两名医院药剂师。检索MEDLINE和EMBASE，以识别1982年1月至1994年3月期间发表的关于IVIG的所有英文综述文章（n = 201）和原始报告（n = 1904）（仅用于人，不包括社论、信件和评论）。由第一作者（T.A.R.）评价相关原始报告（250）和综述文章（87）。提取的数据包括实验室和临床结果、客观测量或临床印象。根据美国预防服务局的研究设计，对证据质量进行分级。特别工作组，协商一致进程。在小组会议之前，一位作者（T.A.R.）编写了一份文献综述和建议草案。本文的建议代表了基于已发表证据的共识（100%一致）。UHC专家组对53种标签外适应症提出了具体建议，并提出了以下一般性建议：（1）通常IVIG仅在标准方法失败、无法耐受或禁忌时才适用;（2）IVIG产品应被视为治疗等效和可互换;（3）在选择IVIG产品时，应根据患者的临床和生理状况考虑产品间的药学差异;和（4）目前，IVIG制造商不能保证成品中没有病毒污染。
Objective.- To summarize consensus recommendations for off-label uses of standard intravenous immunoglobulin (IVIG), as developed by a University Hospital Consortium (UHC) Expert Panel. These findings are intended to help guide clinicians in the appropriate and efficient use of IVIG.Participants.- The UHC-sponsored panel included eight physicians (board certified in critical care, hematology, immunology, neurology, oncology, pediatrics, or rheumatology) and two hospital pharmacists.Evidence.- MEDLINE and EMBASE were searched to identify all English-language review articles (n=201) and original reports (n=1904) on IVIG (human use only, excluding editorials, letters, and comments) published between January 1982 and March 1994. Relevant original reports (250) and review articles (87) were evaluated by the first author (T.A.R.). Extracted data included laboratory and clinical findings, objective measures, or clinical impressions. The evidence quality was graded by study design according to the US Preventive Services. Task Force.Consensus Process.- Before the panel meeting, a draft literature review and recommendations were produced by one of the authors (T.A.R.). The recommendations herein represent consensus (100% agreement) based on the published evidence.Conclusions.- The UHC Expert Panel made specific recommendations for 53 off-label indications and the following general recommendations: (1) Usually IVIG is indicated only if standard approaches have failed, become intolerable, or are contraindicated; (2) IVIG products should be considered therapeutically equivalent and interchangeable; (3) interproduct pharmaceutical differences should be considered with the patient's clinical and physiological status when selecting an IVIG product; and (4) currently, IVIG manufacturers cannot guarantee freedom from viral contamination in the finished product.